FDA Inspection
Mueller-Omicron GmbH & Co. KGMueller-Omicron GmbH & Co. KG – FDA Inspection, Nov 15, 2012
Record Details
This FDA Inspection record concerns Mueller-Omicron GmbH & Co. KG, with an inspection on November 15, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 15, 2012
- Product Type
- Devices
View Company Profile
ID · d3f214e0-58ed-4037-afde-26341c3097ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809889
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.